Breast CancerNCT00896727
S9313A Protein Expression Analysis of Breast Cancer Tissue Microarrays From Clinical Trial SWOG-9313
An observational study of Breast Cancer, run by SWOG Cancer Research Network at 1 site in United States.
Trial summary
RATIONALE: Studying the proteins expressed in tumor tissue samples in the laboratory from patients with cancer may help doctors learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- gene expression analysis, protein expression analysis and fluorescent antibody technique
- How many people
- 2,100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2006to 2 Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients from SWOG 9313 consented to banking
DISEASE CHARACTERISTICS:
- Diagnosis of primary invasive adenocarcinoma of the breast
- Stage I-IIIA disease (T1-3, N0-1, M0)
- Enrolled on clinical trial SWOG-9313
- Tumor tissue available for testing
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Cancer Center
New Haven, Connecticut, 06520-8028
About this study
Official title: Prediction of Therapeutic Response Using AQUA™ Quantitative Protein Expression Analysis of ER, PgR, and HER2 of Breast Cancer Tissue Microarrays From SWOG Protocol 9313
RATIONALE: Studying the proteins expressed in tumor tissue samples in the laboratory from patients with cancer may help doctors learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.
PURPOSE: This laboratory study is looking at protein expression in predicting response to treatment using tumor tissue samples from women with stage I, stage II, or stage IIIA breast cancer treated on clinical trial SWOG-9313.
Read the detailed description
OBJECTIVES:
- Assess in-situ protein expression of estrogen receptor (ER), progesterone receptor (PR), HER-2, and p53 by automated quantitative analysis (AQUA™) and multiplexed analysis at 2 markers per slide using tumor tissue from women with stage I, stage II, or stage IIIA breast cancer treated on clinical trial SWOG-9313.
- Assess the main effects of ER, PR, HER-2, and p53, as well as interactions to generate classes formed by clustering of biomarkers, on a large breast cancer tissue microarray to predict disease-free and overall survival of patients who received high-dose cyclophosphamide and doxorubicin hydrochloride on clinical trial SWOG-9313.
OUTLINE: This is a multicenter study. Patients are stratified according to receptor status and menopausal status.
Tumor tissue samples are analyzed by quantitative protein expression analysis (AQUA™, a fluorescent antibody technique) for estrogen receptor, progesterone receptor, p53 and HER-2. AQUA™ is used to assess markers individually and as ratios with the use of clustering algorithms to define reproducible classifications of tissue from patients treated on SWOG-9313 as a function of molecular classification.
Results of the AQUA™ testing are compared to immunohistochemistry and fluorescent in situ hybridization (FISH) results obtained on SWOG-9313.
- Conditions
- Breast Cancer
- Being tested
- gene expression analysis, protein expression analysis, fluorescent antibody technique, laboratory biomarker analysis
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
protein expression analysisGenetic
fluorescent antibody techniqueOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
In-situ protein expression of estrogen receptor (ER), progesterone receptor (PR), HER-2, and p53 as measured by automated quantitative analysis (AQUA™)
at baseline
Measured: Retrospectively at baseline
Main effects of ER, PR, HER-2, and p53, as well as interactions to generate classes formed by clustering of biomarkers, on a large breast cancer tissue microarray to predict disease-free and overall survival
at baseline
Measured: Retrospectively at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start17 Jul 2006
- Primary completion2 Jan 2009
- Study completion2 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Rimm, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896727
- Sponsor's protocol ID
- CDR0000467801
- Other IDs
- SWOG-S9313-INT-0137-ICSC, NCI-2009-00806
- Status last verified
- Dec 2019
- First submitted
- 9 May 2009
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Therapeutic Response Using AQUA™ Quantitative Protein Expression Analysis of ER, PgR, and HER2 of Breast Cancer Tissue Microarrays From SWOG Protocol 9313
- ClinicalTrials.gov ID
- NCT00896727
- Acronym / sponsor ID
- CDR0000467801
- Conditions
- Breast Cancer
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,100 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jul 2006 (actual)
- Primary completion
- 2 Jan 2009 (actual)
- Study completion
- 2 Apr 2009 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Studying the proteins expressed in tumor tissue samples in the laboratory from patients with cancer may help doctors learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.
PURPOSE: This laboratory study is looking at protein expression in predicting response to treatment using tumor tissue samples from women with stage I, stage II, or stage IIIA breast cancer treated on clinical trial SWOG-9313.
Detailed description
OBJECTIVES:
- Assess in-situ protein expression of estrogen receptor (ER), progesterone receptor (PR), HER-2, and p53 by automated quantitative analysis (AQUA™) and multiplexed analysis at 2 markers per slide using tumor tissue from women with stage I, stage II, or stage IIIA breast cancer treated on clinical trial SWOG-9313.
- Assess the main effects of ER, PR, HER-2, and p53, as well as interactions to generate classes formed by clustering of biomarkers, on a large breast cancer tissue microarray to predict disease-free and overall survival of patients who received high-dose cyclophosphamide and doxorubicin hydrochloride on clinical trial SWOG-9313.
OUTLINE: This is a multicenter study. Patients are stratified according to receptor status and menopausal status.
Tumor tissue samples are analyzed by quantitative protein expression analysis (AQUA™, a fluorescent antibody technique) for estrogen receptor, progesterone receptor, p53 and HER-2. AQUA™ is used to assess markers individually and as ratios with the use of clustering algorithms to define reproducible classifications of tissue from patients treated on SWOG-9313 as a function of molecular classification.
Results of the AQUA™ testing are compared to immunohistochemistry and fluorescent in situ hybridization (FISH) results obtained on SWOG-9313.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from SWOG 9313 consented to banking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expression analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| fluorescent antibody technique | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
In-situ protein expression of estrogen receptor (ER), progesterone receptor (PR), HER-2, and p53 as measured by automated quantitative analysis (AQUA™)
Time frame: Retrospectively at baseline
at baseline
Main effects of ER, PR, HER-2, and p53, as well as interactions to generate classes formed by clustering of biomarkers, on a large breast cancer tissue microarray to predict disease-free and overall survival
Time frame: Retrospectively at baseline
at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Rimm, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by SWOG Cancer Research Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-situ protein expression of estrogen receptor (ER), progesterone receptor (PR), HER-2, and p53 as measured by automated quantitative analysis (AQUA™) (time frame: Retrospectively at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.